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Utility and safety of oral Flecainide (arrhythmia drug) in patients with atrial fibrillation after heart valve (mitral) surgery

Efficacy and safety of Oral Flecainide in acute conversion of Atrial Fibrillation followed by short term maintenance therapy in patients who have undergone Mitral valve replacement/ repair

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/010144
Enrollment
100
Registered
2017-10-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Atrial fibrillation in patients who have undergone mitral valve replacement/ repair

Interventions

Intervention1: Flecainide: Patients in this group will receive Flecainide after ensuring adequate AV nodal blockade with either β blockers or Calcium channel blockers. Patients will be given a single

Sponsors

Torrent Pharmaceuticals Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with rheumatic mitral valve disease who have undergone mitral valve replacement/ repair (3 to 6 months post surgery) 2.Patients > 15 years of age 3.Patients with chronic AF 4.Patients giving written informed consent

Exclusion criteria

Exclusion criteria: 1.Patients intolerant of β blockers or Diltiazem or having a ventricular rate 2.Patients with a LA > 60 mm in any diameter or LA volume > 216 cm3 3.Patients 4.Patients with LV dysfunction 5.Inability to comply with the follow-up period 6.Patients not giving written consent for inclusion in the trial

Design outcomes

Primary

MeasureTime frame
Maintenance of sinus rhythm at 6 monthsTimepoint: Maintenance of sinus rhythm at 6 months—

Secondary

MeasureTime frame
Occurrence of pro-arrhythmic events in patients receiving oral Flecainide therapyTimepoint: QRS duration will be monitored with standard/EASI derived 12 lead ECG at 25 and 50 mm/s speed prior to the first dose and then before every dose for a total of 3 doses. Patients will be followed up at 1 week, 3 months and 6 months. Holter monitoring will be done at or after 6 months in patients who are maintaining sinus rhythm.—

Countries

India

Contacts

Public ContactDr Faraz Ahmed Farooqui

AIIMS

neerajparakh@yahoo.com9999223327

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026